USFDA accepts GSK depemokimab applications for review for asthma, chronic rhinosinusitis
London: GSK plc has announced the US Food and Drug Administration (FDA) has accepted for review the Biologics License Application for the use of depemokimab in two indications.
The proposed indications are as add-on maintenance treatment of asthma in adult and pediatric patients aged 12 years and older with type 2 inflammation characterised by an eosinophilic phenotype on medium- to high-dose inhaled corticosteroids (ICS) plus another asthma controller and, as add-on maintenance treatment in adult patients with inadequately controlled chronic rhinosinusitis with nasal polyps (CRSwNP).
The Prescription Drug User Fee Act (PDUFA) date is 16 December 2025.
Kaivan Khavandi, SVP and Global Head, Respiratory, Immunology & Inflammation R&D, GSK, said, “Simultaneous regulatory submissions for two indications highlight our confidence in depemokimab to help reduce the burden of both asthma and CRSwNP for patients and health systems. Our SWIFT and ANCHOR trials support depemokimab’s potential to suppress interleukin-5 (IL-5), a known driver of type 2 inflammation, to offer patients sustained inhibition of a key driver of their disease with just two doses per year.”
Depemokimab, a monoclonal antibody that targets IL-5, is a ultra-long-acting biologic to be evaluated in phase III trials and be accepted for regulatory review for use in these conditions. Depemokimab's extended half-life, high-binding affinity and potency, support six month (26 week) dosing regimens based on results from the SWIFT and ANCHOR trials. In patients with asthma with type 2 inflammation and patients with CRSwNP, these trials met their primary endpoints, showing that depemokimab could offer sustained inhibition of a key driver of their disease, and help achieve key clinical outcomes with a dosing schedule of just two injections per year. As demonstrated in studies of other diseases, longer intervals between doses have been shown to overcome barriers to optimal care, such as patient adherence.
IL-5 is a key cytokine (protein) in type 2 inflammation. Type 2 inflammation is typically identified by blood eosinophil count and is an underlying driver in many diseases. This type of inflammation is present in the majority of patients with difficult to treat asthma and can lead to exacerbations and hospitalisation. Type 2 inflammation is also present in up to 85% of people with CRSwNP and is associated with more severe disease and symptoms.
In the United States, more than 26 million people are currently affected by asthma, 40% of whom report having had at least one asthma attack in the previous year which contributes to significant burden this condition exerts on healthcare resources and the lives of patients.
In the United States, 2.1% of the population are affected by chronic rhinosinusitis, up to 30% of whom have nasal polyps.8 People with CRSwNP experience symptoms such as nasal obstruction, loss of smell, facial pain, sleep disturbance, infections and nasal discharge that can significantly affect their emotional and physical well-being. Such symptoms mean the impact of CRSwNP on overall quality of life has been reported to be comparable with other chronic diseases such as COPD, asthma, and diabetes.
Depemokimab is currently not approved for use in any country.
